Skip to content

Sandare Glycohemoglobin Procedure

by Sandare Chemical Co., Inc. 510(k)

Active United States

510(k) K802832

Overview

The Sandare Glycohemoglobin Procedure is an assay for glycosylated hemoglobin, classified as a Class 2 device. It is used in the field of hematology. The device is substantially equivalent to other devices on the market.

The Sandare Glycohemoglobin Procedure is supplied with a product code of LCP and is regulated under the regulation number 864.7470. It has been cleared through the FDA 510k pathway and has a decision date of 1981-01-16. The device is listed with the FDA and has a registration number associated with it.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802832 Date16 Jan 1981ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LCP
Device Class
Class II
Regulation
21 CFR Part 864.7470
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Other devices from Sandare Chemical Co., Inc.

See all devices from Sandare Chemical Co., Inc. →

Questions

  • What is the Sandare Glycohemoglobin Procedure used for?

    The Sandare Glycohemoglobin Procedure is used to assay glycosylated hemoglobin in the field of hematology.

  • How is the device supplied?

    The device is supplied with a product code of LCP and is regulated under the regulation number 864.7470.

  • Is the Sandare Glycohemoglobin Procedure a single-use or reusable device?

    The device description does not specify whether it is single-use or reusable, but it is classified as a Class 2 device.

  • What is the regulatory status of the Sandare Glycohemoglobin Procedure?

    The device has been cleared through the FDA 510k pathway with a decision date of 1981-01-16 and is listed with the FDA.